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510(k) K883427

VIRGO(R) VZV-IGG ELISA by Electro-Nucleonics, Inc. — Product Code GQX

K883427 is an FDA 510(k) premarket notification submitted by Electro-Nucleonics, Inc. for the device "VIRGO(R) VZV-IGG ELISA". The FDA issued a decision of Substantially Equivalent on March 10, 1989. The device falls under product code GQX (Antiserum, Cf, Varicella-Zoster), a Class II device regulated under 21 CFR 866.3900. Electro-Nucleonics, Inc. has at least 8 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 10, 1989
Date Received
August 15, 1988
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Antiserum, Cf, Varicella-Zoster
Device Class
Class II
Regulation Number
866.3900
Review Panel
MI
Submission Type

Other clearances by Electro-Nucleonics, Inc.

  • K893718 — DELTATEST (R) LIPASE II (September 28, 1989)
  • K883670 — SEROLOGICAL TEST KIT FOR IGG ANTI. EPSTEIN-BARR VI (April 28, 1989)
  • K883281 — VIRGO HSV-2 IGG ELISA (March 10, 1989)
  • K883282 — VIRGO HSV-1 IGG ELISA (March 10, 1989)
  • K883102 — VIRGO (R) CMV-IGG ELISA (February 8, 1989)
  • K884784 — VIRGO(R) MICROWELL ALT ASSAY (December 29, 1988)
  • K883205 — ALTLTS ALANINE AMINO TRANSFERASE ALT (September 9, 1988)
  • K883206 — LACTATE DEHYDROGENASE LDH (September 9, 1988)

Other clearances for product code GQX

  • K951799 — VARICELLA-ZOSTER VIRUS DIRECT IMMUNOFLUORESCENCE ASSAY (March 20, 1996)
  • K911301 — VZV IGM TEST (July 17, 1991)
  • K875358 — VZV TEST (March 31, 1988)
  • K863317 — ENZYGNOST ANTI-VZV IGG TEST (April 22, 1987)
  • K853540 — FIAX TEST KIT FOR VARICELLA ANTIBODY SEROLOGY (February 4, 1986)
  • K852930 — VARICELLA-ZOSTER-COMPLE FIX ANTIGEN AND NEG CONTRO (November 12, 1985)
  • K842096 — GLB VARICELLA-ZOSTER VIRUS FLUORESCENT (January 7, 1985)
  • K841526 — ORTHO VARICELLA-ZOSTER VIRUS IDENT. (June 25, 1984)
  • K770810 — VARICELLA-ZOSTER FA LABELED PRESERUM (May 20, 1977)
  • K770806 — VARICELLA-ZOSTER FA LABELLED (8-321 RF) (May 20, 1977)

FDA data resources